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Out of Control - 09/09/03

An
ongoing look at the poor quality of vaccine research

One of the biggest challenges facing those of us concerned about
vaccine safety and effectiveness is the widespread disbelief that
considerable vaccine damage could be occurring. While this
perception can probably be blamed on a variety of factors, overcoming
it at least partly depends on exposing the generally poor
quality of vaccine research.

One aspect that bears particular attention is the fact that vaccine
studies lack a genuine control group.

Indeed, it is hard to believe that something so basic to good study
design could be lacking. Yet it is true. Consequently,
there is a great need for solid reporting on this basic issue. (For
more on "never vaccinated" subjects not being included in vaccine
safety studies, click here.)

To that end, OUT OF CONTROL was born. Periodically, as time
permits, a poorly designed study will be examined, in an effort to
illustrate the fundamental nature of the problem.

Also to that end, I issue an open challenge to anyone to come up with
pro-vaccine safety studies which do use "never vaccinated" children as
controls. These studies will be acknowledged and posted here, if
and when they can be verified.

The CDC reported on a study they conducted in which a large number of
children (167,240) were followed from birth for between 18 months and 6
years, using HMO records. The stated purpose was to see if
vaccination increased the incidence of asthma.

As is typically the case in vaccine safety studies, all children in the
study appear to have been vaccinated with one or more vaccines.
While it is not absolutely clear whether or not any of the children
included in the study had never been vaccinated, what is clear is the
following: no comparison to a group of "never vaccinated" children is
ever made in the tables or the text.

As is common in studies of this kind, the term "unvaccinated" was used
instead of "never vaccinated". In practice, unvaccinated usually
either means a subject was not vaccinated with the comparison vaccine,
or had not been recently vaccinated with it. The former definition
appears to apply in this study.

For instance, in this study, a comparison was made between those who
had been given the DPT vaccine and those who had not, as to asthma
incidence. Those not given DPT, however, appear to have all
received at least one vaccine other than DPT, and to have been included
in at least one other vaccinated group. Other such similar
comparisons were made, but in all cases the children appear to have
been vaccinated at least once.

If there actually was a group of never vaccinated children in the
study, absolutely no reference to them is ever made. The risk of
getting asthma is computed for DPT, OPV, MMR, Hib and Hep B vaccines,
but not for a group that was never vaccinated.
Not surprisingly, in most cases, little difference was found between
those who had been vaccinated with the various vaccines in terms of the
incidence of asthma. Where there appeared to be a small,
increased risk (in the case of Hib and Hep B vaccines), there was an
attempt to explain away the results.

The authors of this study also shamelessly criticized a New Zealand study,
which had found evidence for increased asthma and atopy, for its
small sample of "unvaccinated kids". I say "shamelessly" because
the NZ study at least made an effort to include unvaccinated kids,
i.e., "never" vaccinated children, whereas the CDC study did not.
Thus the New Zealand study results, although not very powerful due to
the never vaccinated group's small sample size, genuinely provided some
provocative evidence that at least one vaccine, DPT, might
increase the incidence of asthma and atopy.

The authors also provided an excellent example of how one flawed study
is used to bolster another. A study from
Sweden, touted as the "methodologically strongest" study providing
evidence against there being a relationship between vaccines and
asthma/atopy, also had no control ("never vaccinated") group.

Although the CDC "study" is
likely to be used to support the notion that vaccines have nothing to
do with the disturbing
increase in the incidence of asthma, it does no such thing.

This "study" essentially shows that
all of the vaccines included more or less result in the same
incidence of asthma.

There appears to be NO control group,
i.e., those who had NO vaccinations at all, ever. This study,
then, says nothing about what the incidence of asthma is in
the absence of vaccination.

"I know of no safe depository of the ultimate powers of the society but the people themselves, and if we think them not enlightened enough to exercise control with a wholesome discretion, the remedy is not to take it from them, but to inform their discretion by education."

-- Thomas Jefferson, letter to William C. Jarvis, September 28, 1820

“A sacred cow will not protect the herd.”

-- Sandy Gottstein

"What's the point of vaccination if it doesn't protect you from the unvaccinated?"

-- Sandy Gottstein

"Who gets to decide what the greater good is and how many will be sacrificed to it?"